A proposed consent process in studies that use an exception to informed consent

Area of Science:

• Emergency medicine
• Clinical research ethics
• Trauma resuscitation

Background:

• Federal regulations permit informed consent exceptions in emergency research.
• Acute traumatic hemorrhagic shock presents challenges for obtaining timely informed consent.
• Diaspirin cross-linked hemoglobin (DCLHb) efficacy trials require careful consideration of patient consent.

Purpose of the Study:

• To describe a novel informed consent process for emergency research involving DCLHb in trauma patients.
• To ensure patient best interests are met when obtaining consent is not feasible.
• To detail the implementation of consent exceptions in a multicenter trial.

Main Methods:

• A multicenter, randomized, single-blinded trial of DCLHb in acute traumatic hemorrhagic shock.
• Development and review of institutional processes for informed consent exceptions.
• Implementation of a multi-faceted consent strategy including prospective, abbreviated, and continuing consent.
• Independent physician approval for consent exceptions prior to enrollment.

Main Results:

• The proposed process integrates prospective patient/LAR consent, consent exceptions, and consent to continue.
• Multiple mechanisms allow for consent or decline before and after enrollment.
• Ongoing case-by-case review by the scientific review committee facilitates process enhancement.

Conclusions:

• The described informed consent process maximizes communication between researchers, patients, proxies, and review committees.
• This ethical framework supports emergency research while protecting patient rights.
• The process allows for flexibility and continuous improvement in consent procedures.